Trials / Completed
CompletedNCT02151812
Comparison of Agent™ and SeQuent® Please Paclitaxel Coated Balloon Catheters in Coronary In-stent Restenosis (AGENT-ISR)
A Prospective Randomized Multicenter Non-inferiority Clinical Study to Determine the Safety and Performance of the Agent™ Paclitaxel-Coated PTCA Balloon Catheter (Hemoteq) Compared to the SeQuent® Please Paclitaxel-Releasing Coronary Balloon Catheter (B.Braun) for the Treatment of Coronary In-Stent Restenosis (AGENT-ISR)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 123 (actual)
- Sponsor
- Hemoteq AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is determine the safety and performance of the Agent™ Paclitaxel-Coated PTCA Balloon Catheter compared to the SeQuent® Please Paclitaxel-Releasing Coronary Balloon Catheter for the treatment of patients with narrowed previously-stented coronary arteries (in-stent restenosis). The performance will be determined at six months post-procedure by quantitative coronary angiography (QCA) to measure Late Lumen Loss (LLL) in the re-opened stented segment. QCA results will be assessed by an independent, blinded angiographic core lab. Study statistical hypothesis: The loss of in-stent luminal diameter at six months after treatment of the restenosed stent with the Agent™ study device is not larger than the respective LLL after treatment with the SeQuent® Please control devices, i.e. study device is non-inferior to the control device with respect to LLL.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Agent Paclitaxel-coated balloon | After successful pre-dilatation, the index lesion is dilated with a single drug-coated balloon that completely covers the restenotic lesion. |
| DEVICE | SeQuent® Please Paclitaxel-coated Balloon | After successful pre-dilatation, the index lesion is dilated with a single drug-coated balloon that completely covers the restenotic lesion. |
Timeline
- Start date
- 2014-08-13
- Primary completion
- 2017-04-27
- Completion
- 2019-10-28
- First posted
- 2014-05-30
- Last updated
- 2019-12-23
Locations
12 sites across 2 countries: France, Germany
Source: ClinicalTrials.gov record NCT02151812. Inclusion in this directory is not an endorsement.